FDA.reportPublic FDA data

Gabapentin

Product NDC
70518-2912
11-digit product format
705182912
Labeler code
70518
Product ID
70518-2912_4ab89b95-2091-c7aa-e063-6294a90ad9ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA206402
Marketing category
ANDA
Marketing start
2020-10-20
Substance
GABAPENTIN
Active strength
800 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310434

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2912-02023-03-13C16284748780-1f386c649-d399-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
70518-2912-02023-01-30C16284748780-1f386c649-d399-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2912-0Gabapentin100 in 1 BOXTABLET1009
70518-2912-1Gabapentin1 in 1 POUCHTABLET19
70518-2912-2Gabapentin100 in 1 BOXTABLET1009
70518-2912-3Gabapentin1 in 1 POUCHTABLET19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2912GABAPENTIN TABLET [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 4 package rows20250406_bc525ae4-9843-4038-a1b7-0d3543e2282c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSNbc525ae4-9843-4038-a1b7-0d3543e2282c9
310434gabapentin 800 MG Oral TabletSCDbc525ae4-9843-4038-a1b7-0d3543e2282c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2912-070518291200100 POUCH in 1 BOX (70518-2912-0) > 1 TABLET in 1 POUCH (70518-2912-1) 100 pouch2020-10-200000-00-00NoNoCurrent
70518-2912-1705182912011 in 1 POUCHHistorical
70518-2912-270518291202100 POUCH in 1 BOX (70518-2912-2) / 1 TABLET in 1 POUCH (70518-2912-3) 100 pouch2023-03-19NoNoCurrent
70518-2912-3705182912031 in 1 POUCHHistorical